Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

Stopped early · Phase 3

Conditions studied: Cryptosporidiosis, HIV Infections

In brief

The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

Key facts

Study ID

NCT00004986

Run by

Romark Laboratories L.C.

People needed

30

Starts

2000-02-01

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have a CD4 cell count of 50 cells/mm3 or less.
• Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
• Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
• Are able to take medications by mouth.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• Agree to use an effective method of birth control (such as condoms) during the study.

You may not qualify if…

• Patients will not be eligible if they:
• Have certain diseases or infections of the intestines.
• Have ever taken nitazoxanide.
• Have taken certain experimental drugs within 14 days of enrollment.
• Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
• Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
• Are pregnant or breast-feeding.

Where it is running

• Julie Ryner — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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